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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002748
Receipt No. R000003242
Scientific Title Response-Guided Interferon Therapy for patients with chronic hepatitis C of the Genotype 1 high viral load: Japanese multi-center, randomized controlled study: (ReGIT-J study)
Date of disclosure of the study information 2009/11/11
Last modified on 2016/11/16

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Basic information
Public title Response-Guided Interferon Therapy for patients with chronic hepatitis C of the Genotype 1 high viral load: Japanese multi-center, randomized controlled study: (ReGIT-J study)
Acronym Response-Guided Interferon Therapy for patients with chronic hepatitis C : Japanese multi-center, randomized controlled study: (ReGIT-J study)
Scientific Title Response-Guided Interferon Therapy for patients with chronic hepatitis C of the Genotype 1 high viral load: Japanese multi-center, randomized controlled study: (ReGIT-J study)
Scientific Title:Acronym Response-Guided Interferon Therapy for patients with chronic hepatitis C : Japanese multi-center, randomized controlled study: (ReGIT-J study)
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examined treatment method and duration from the HCV-RNA negativity time in an PEG-IFN alfa-2 a/RBV combination therapy or a PEG-IFNalfa-2a/RBV combination therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Virological response:SVR
HCVRNA negativity of 24 weeks of end of treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 8
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 PEG-IFN alfa-2a monotherapy in the patients who undetectable HCV-RNA at week 4
Interventions/Control_2 PEG-IFNalfa-2a/Ribavirin combination therapy in the patients who undetectable HCV-RNA at week 4
Interventions/Control_3 PEG-IFN alfa-2a once a week/ Ribavirin combination therapy in the patients who detectable HCV-RNA at week 4 but undetectable HCV-RNA at week 12
Interventions/Control_4 PEG-IFN alfa-2a biweekly/Ribavirin combination therapy in the patients who detectable HCV-RNA at week 4 but undetectable HCV-RNA at week 12
Interventions/Control_5 PEG-IFNalfa-2a/Ribavirin combination therapy in the patients who detectable HCV-RNA at week 12 but undetectable HCV-RNA at week 24
Interventions/Control_6 PEG-IFNalfa-2a/Ribavirin/Fluvastatin combination therapy in the patients who detectable HCV-RNA at week 12 but undetectable HCV-RNA at week 24
Interventions/Control_7 PEG-IFN alfa-2a half dose long term maintenance therapy in the patients who detectable HCV-RNA at week 24
Interventions/Control_8 A treatment cancellation follow-up in the patients who detectable HCV-RNA at week 24
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Existence of previous treatment (interferon therapy including a Ribavirin combined therapy) is not asked.
2.Genotype1,more than HCV-RNA 100KIU/ml
3.Baseline of the following clinical laboratory test result / before a medication start -- the patient who filled all
WBC count : more than3,000/mm3
neutrophil count: more than 1,500/mm3
PLT count:more than 90,000/mm3
Hemoglobin content :more than12g/dl
4.The patient by sufficient understanding top after being given ( sufficient ) in participation of an exam, and a document -- the patient by whom the consent by the free intention of the person himself/herself was got
Key exclusion criteria 1.A pregnant woman, the woman who may have become pregnant, or the woman under breastfeeding
2.The patient who has an anamnesis of hypersensitivity to the ingredient or other nucleoside analogs of this agent (acyclovir, ganciclovir, Bidarabin, etc.)
3.A patient with cardiac disease (myocardial infarction, heart failure, abnormal heart rhythm etc.) with difficult control
4.The patient of abnormal hemoglobin diseases (sarasemia, drepanocytic anemia, etc.)
5.The patient to whom the following renal dysfunction has chronic renal failure or a creatinine clearance by 50mL/min
6.A patient with the patient in serious mental disease states, such as serious depression, suicide ideation, or a suicide attempt, or its anamnesis
7.A critical impaired liver function patient
8.The patient of autoimmune hepatitis
9.The patient who is prescribing Syousaikotou
10.The chronic liver disease patient of others, such as autoimmune hepatitis and alcoholic hepatitis
11.The patient who has an anamnesis of hypersensitivity to the ingredient or other interferon tablets of this agent
12.The patient who has an anamnesis of hypersensitivity to biological preparation, such as a vaccine
13.The patient of liver cirrhosis, hepatic insufficiency, and cancer of liver
14.The patient who meets at least one standard of the following clinical laboratory test result / before a medication start
before treatment
WBC count Less than 3,000/mm3
neutrophil count Less than 1,500/mm3
PLT count Less than 90,000/mm3
Hemoglobin content Less than 12g/dl
15.In addition, the patient whom the examination doctor in attendance judged that the participation to an exam is unsuitable

Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuhei Nishiguchi
Organization Hyogo College Of Medicine
Division name Division of Hepatobiliary and Pancreatic Diseases Department of Internal Medicine
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL 0798-45-6472
Email

Public contact
Name of contact person
1st name
Middle name
Last name Teruhisa Yamamoto
Organization Hyogo College Of Medicine
Division name Division of Hepatobiliary and Pancreatic Diseases Department of Internal Medicine
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL 0798-45-6472
Homepage URL
Email

Sponsor
Institute Hyogo College Of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization None

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 石切生喜病院(大阪府)、大阪医科大学(大阪府)、大阪赤十字病院(大阪府)、
関西医科大学附属枚方病院(大阪府)、関西医科大学附属滝井病院(大阪府)、
近畿大学(大阪府)、神戸朝日病院(兵庫県)、新生病院(大阪府)、摂津ひかり病院(大阪府)、
大正病院(大阪府)、田辺中央病院(大阪府)、兵庫医科大学(兵庫県)、枚方市民病院(大阪府)、
北摂総合病院(大阪府)、牧病院(大阪府)、守口敬仁会病院(大阪府)、
わかこうかい病院(大阪府)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 05 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 11 Day
Last modified on
2016 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003242

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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